November 2, 2015
ROADSTER 2 Postapproval Registry Begins for Silk Road Medical's Enroute NPS
November 2, 2015—Silk Road Medical, Inc. announced that the first patient was enrolled in the ROADSTER 2 United States postapproval registry. ROADSTER 2 is a prospective, multicenter study designed to assess the company’s Enroute transcarotid neuroprotection and stent system in the real-world treatment of patients at risk for stroke, caused by carotid artery disease. The Enroute system, which received US Food and Drug Administration 510(k) clearance in February 2015, is designed specifically for transcarotid artery revascularization (TCAR).
The ROADSTER 2 study is a follow-up to the ROADSTER study, which evaluated the TCAR procedure in 141 patients at high risk for complications from surgery with a composite primary endpoint result of 3.5% for stroke, death, or myocardial infarction through 30 days.
According to Silk Road Medical, the prospective study will include a minimum of 600 patients at up to 100 sites. The ROADSTER 2 study is being led by co-national Principal Investigators Peter A. Schneider, MD, Chief of Vascular at Kaiser Foundation Hospital in Honolulu, Hawaii, and Vikram Kashyap, MD, Chief of Vascular and Endovascular Surgery, University Hospitals Case Medical Center, Cleveland, Ohio.
The first patient in ROADSTER 2 was enrolled at Greenville Memorial Hospital in Greenville, South Carolina. Bruce Gray, MD, performed the procedure with Mark Androes, MD, and Joseph Blas, MD.
In the company’s press release, Dr. Gray stated, “TCAR, with the Enroute transcarotid system, represents the modernization of carotid repair. With traditional surgical repair where we cut open the neck and carotid artery, there is always an underlying risk of serious complications including heart attack and nerve injury. The TCAR procedure combines surgical principles of protecting the brain with advanced endovascular stent technology to treat patients in a far less invasive and safe manner.”
Also commenting in Silk Road Medical’s announcement, Dr. Kashyap stated, “In the ROADSTER study, we achieved the lowest reported 30-day stroke rate of any prospective study of carotid revascularization at 1.4% in the intent-to-treat patient population and 0.7% in the per-protocol population. Importantly, there were no strokes in high risk subgroups, including symptomatic patients, elderly patients over the age of 75, and female patients. We look forward to building upon this excellent clinical evidence base in the ROADSTER 2 study.”
Dr. Schneider added, “We have been seeking a less-invasive alternative to traditional carotid surgery. With TCAR and the Enroute transcarotid platform we have incorporated decades of learning from surgical and endovascular techniques into a hybrid procedure that has shown impressive clinical results to date. Dr. Kashyap and I are looking forward to partnering with the ROADSTER 2 investigators to evaluate this important innovation. This is a real opportunity to impact stroke prevention efforts in the United States and around the world.”